In order to build a medical device supervision system scientifically and to speed up the integration with international standards, the third edition of "Basic Principles of Medical Device Safety and Performance" issued by IMDRF (hereinafter referred to as "Basic Principles") was equivalently converted by China in March 2020.

The "Basic Principles" are the basic requirements for the safety and effectiveness of medical devices based on general risks. Registrants should consciously fulfill their responsibilities and integrate requirements of the "Basic Principles" into the R&D and production process of medical devices. Under the quality management system, related documents can be used as supportive documents and as evidence of safety and effectiveness during the registration.

In order to further guide registrants to develop products and register licenses scientifically and rationally according to the "Basic Principles", as well as to ensure the safety and effectiveness of medical devices, the Center for Medical Device Evaluation (CMDE) has formulated the “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>”, which is hereby issued.

 

Attachment:

1. Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>

2. Instructions of Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>

 

 

Reference:
NMPA’s Notice of the CMDE on Issuing Technical Guidelines for the Compliance of the Basic Principles of Medical Device Safety and Performance (No. 29, 2022)

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